Pharmaceutical Inspection Co-Operation Scheme Sets 2017-2019 Goals

The Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding, informal co-operative arrangement between regulatory authorities in the field of good manufacturing practice (GMP) of medicinal products for human or veterinary use, has issued an action plan that sets goals for the organization over the next two years. The key priorities for the 2017-2019 action plan include training, developing strategic development and communications, regulatory authority compliance, and harmonization of GMP/good distribution practice (GDP) guidance.

Training remains PIC/S’ most important field of activity following the launch of the PIC/S Inspectorates’ Academy (PIA) in July 2016. The PIC/S notes that resources for PIA should be increased and related financing considered. Considerations will be given on the training of inspectors on the revised Annex 1 of sterile manufacturing in the PIC/S GMP Guide and instruments to measure the efficacy of PIC/S training events will be introduced.

In terms of strategic development and communication, PIC/S aims to better communicate with heads of agencies for increased support, including developing an annual work plan to present PIC/S’ future goals and achievements and increase its visibility. PIC/S will work toward improved cooperation with the International Coalition of Medicines Regulatory Authorities (ICMRA) on an ICMRA GMP project and on a Unique Facility Identifier (UFI) project as well as a PIC/S survey on the acceptance of “same scope inspection results”.

Another key priority for PIC/S is the continued compliance of participating authorities, which is important for maintaining equivalent GMP systems. To that end, PIC/S will focus on a joint reassessment program and will implement desktop assessments. PIC/S will also consider establishing a dedicated resource pool of auditors to undertake new assessments and may introduce an annual reporting system on key indicators of PIC/S participating authorities.

The harmonization of GMP/GDP is another major priority, and PIC/S will consider whether to strengthen its position in areas such as advanced therapy medicinal products (ATMPs), veterinary medicinal products, investigational medicinal products, or emerging technologies. PIC/S plans to introduce instruments to measure the use/implementation of guidance documents and complete a library project that provides an index of GMP guidance resources from PIC/S participating authorities. PIC/S has expert circle groups active in several fields, including active pharmaceutical ingredients, quality risk management, GDP, and blood, tissues, cells, and ATMPs. These expert circle groups operate under different organizational rules than sub-committees and working groups, but to be consistent, the rules across the various groups should be aligned, PIC/S said. The size of co-ordinating committees will be increased in order to facilitate the running of expert circle meetings, and scientific committees in charge of reviewing the scientific program of expert circle meetings will be activated.

PIC/S has noted that in the field of ATMPs, there is a risk of GMP being dis-harmonized by the European Commission’s (EC) proposed stand-alone ATMP GMP guidelines. This initiative by the EC, launched in 2015 and which will lead to a revision of EU GMP Guide Annex 2 on biological products, is expected to result in the PIC/S GMP Guide and the EU GMP Guide no longer being equivalent, according to PIC/S. Since 1989, both guides have been developed in parallel and systematically kept aligned on the basis of a harmonized consultation procedure between PIC/S and the European Medicines Agency. Lack of international harmonization in this guidance is expected to potentially impact the availability of ATMP across regions regulated by PIC/S participating authorities as well as cause regulatory burden for manufacturers which will have to comply with different codes, according to PIC/S.